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European Union Approves Brinzolamide/Timolol Suspension for the Treatment of Glaucoma, Ocular Hypertension
NEW YORK -- December 3, 2008 -- The European Medicines Agency has approved the fixed combination brinzolamide 10 mg/mL plus timolol 5 mg/mL (Azarga) ophthalmic suspension for the treatment of elevated intraocular pressure (IOP) associated with open-angle glaucoma or ocular hypertension in adult patients for whom monotherapy provides insufficient IOP reduction.
The approval is based on 2 studies that showed brinzolamide/timolol to be more comfortable and better tolerated by patients than dorzolamide plus timolol (Cosopt). In a patient preference study comparing the 2 solutions, 79% of patients with glaucoma expressed a preference to brinzolamide/timolol.
The studies also showed that the active ingredients in the brinzolamide/timolol suspension were more effective when delivered in combination than either of them individually.
Brinzolamide/timolol demonstrated superior IOP-lowering efficacy at every time point measured in the study versus the individual components alone, while demonstrating a similar safety profile. In addition, a head-to-head study showed that brinzolamide/timolol provides IOP lowering efficacy that is similar to dorzolamide/timolol.
SOURCE: Alcon, Inc.
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